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Phase III IMpower131 Study Showed Genentech’s TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People with a Type of Advanced Squamous Lung Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the Phase III IMpower131 study met its co-primary
endpoint of progression-free survival (PFS) and demonstrated that the
combination of TECENTRIQ® (atezolizumab) plus chemotherapy
(carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel])
reduced the risk of disease worsening or death (progression-free
survival; PFS) compared with chemotherapy alone in the initial
(first-line) treatment of people with advanced squamous non-small cell
lung cancer (NSCLC). Safety for the TECENTRIQ and chemotherapy
combination appeared consistent with the known safety profile of the
individual medicines, and no new safety signals were identified with the
combination. At this interim analysis a statistically significant
overall survival (OS) benefit was not observed and the study will
continue as planned. These data will be presented at an upcoming
oncology congress.

“Squamous non-small cell lung cancer is difficult to treat and there
have been limited new treatment options over the last few decades,” said
Sandra Horning, M.D., chief medical officer and head of Global Product
Development. “We will share the IMpower131 results with global health
authorities and we look forward to seeing more mature overall survival
data.”

As per the statistical analysis plan in IMpower131, Arm B (TECENTRIQ
plus carboplatin and nab-paclitaxel) must demonstrate a
statistically significant OS result vs. Arm C (carboplatin and nab-paclitaxel),
before an analysis between Arm A (TECENTRIQ plus carboplatin and
paclitaxel) and Arm C can be made for PFS and OS.

Currently, Genentech has eight Phase III lung cancer studies underway
evaluating TECENTRIQ alone or in combination with other medicines, and
five are expected to report this year.

About the IMpower131 study

IMpower131 is a Phase III, open-label, multicenter, randomized study
evaluating the efficacy and safety of TECENTRIQ in combination with
carboplatin and nab-paclitaxel or TECENTRIQ in combination with
carboplatin and paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel)
alone in people with stage IV squamous NSCLC who have not been
previously treated with chemotherapy. The study enrolled 1,021 people
who were randomized equally (1:1:1) to receive:

TECENTRIQ plus carboplatin and paclitaxel (Arm A), or

TECENTRIQ plus carboplatin and nab-paclitaxel (Arm B), or

Carboplatin and nab-paclitaxel (Arm C, control arm)

During the treatment-induction phase, people in Arm A received four or
six cycles of TECENTRIQ plus carboplatin and paclitaxel, given on day
one of each 21-day cycle. This was followed by maintenance therapy with
TECENTRIQ every three weeks until progression of the cancer, or for as
long as clinical benefit was observed.

During the treatment-induction phase, people in Arm B received four or
six cycles of TECENTRIQ, carboplatin and nab-paclitaxel.
TECENTRIQ and carboplatin were administered on day one of each 21-day
cycle. Nab-paclitaxel was administered on days one, eight and 15
of each 21-day cycle. This was followed by maintenance therapy with
TECENTRIQ every three weeks until progression of the cancer, or for as
long as clinical benefit was observed.

During the treatment-induction phase, people in Arm C received four or
six cycles of carboplatin and nab-paclitaxel. Carboplatin was
administered on day one of each 21-day cycle, and nab-paclitaxel
was administered on days one, eight and 15 of each 21-day cycle. In the
maintenance phase, participants received best supportive care.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1 in the
intention-to-treat (ITT) population (Arm B vs. Arm C)

According to the American Cancer Society, it is estimated that more than
234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC
accounts for 85 percent of all lung cancers. It is estimated that
approximately 60 percent of lung cancer diagnoses in the United States
are made when the disease is in the advanced stages.

About TECENTRIQ® (atezolizumab)

TECENTRIQ is a monoclonal antibody designed to bind with a protein
called PD-L1. TECENTRIQ is designed to bind to PD-L1 expressed on tumor
cells and tumor-infiltrating immune cells, blocking its interactions
with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may
enable the re-activation of T cells. TECENTRIQ may also affect normal
cells.

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly
owned subsidiary of Celgene Corporation.

TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)

TECENTRIQ is a prescription medicine used to treat:

a type of bladder and urinary tract cancer called urothelial
carcinoma.

TECENTRIQ may be used when your bladder cancer:

has spread or cannot be removed by surgery (advanced urothelial
carcinoma), and

you are not able to take chemotherapy that contains a medicine
called cisplatin, or

you have tried chemotherapy that contains platinum, and it did not
work or is no longer working.

The approval of TECENTRIQ in these patients is based on a study that
measured response rate and duration of response. There is an ongoing
study to confirm clinical benefit.

a type of lung cancer called non-small cell lung cancer (NSCLC)

TECENTRIQ may be used when your lung cancer:

has spread or grown, and

you have tried chemotherapy that contains platinum, and it did not
work or is no longer working.

If your tumor has an abnormal EGFR or ALK gene, you should have also
tried an FDA-approved therapy for tumors with these abnormal genes, and
it did not work or is no longer working.

It is not known if TECENTRIQ is safe and effective in children.

Important Safety Information

Important Information About TECENTRIQ

TECENTRIQ can cause the immune system to attack normal organs and
tissues in many areas of the body and can affect the way they work.
These problems can sometimes become serious or life-threatening and can
lead to death.

Getting medical treatment right away may help keep these problems
from becoming more serious. A healthcare provider may treat a
patient with corticosteroid or hormone replacement medicines. A
healthcare provider may delay or completely stop treatment with
TECENTRIQ if a patient has severe side effects.

Patients should call or see their healthcare provider right away if
they get any symptoms of the following problems or these symptoms get
worse.

TECENTRIQ can cause serious side effects, including:

Lung Problems (pneumonitis) – Signs and symptoms of
pneumonitis may include: new or worsening cough, shortness of breath,
or chest pain

Liver Problems (hepatitis) – Signs and symptoms of
hepatitis may include: yellowing of the skin or the whites of the
eyes, severe nausea or vomiting, pain on the right side of the stomach
area (abdomen), drowsiness, dark urine (tea colored), bleeding or
bruising more easily than normal, feeling less hungry than usual

Intestinal Problems (colitis) – Signs and symptoms of
colitis may include: diarrhea (loose stools) or more bowel movements
than usual, blood in the stools or dark, tarry, sticky stools, severe
stomach area (abdomen) pain or tenderness

Hormone Gland Problems (especially the pituitary, thyroid, adrenal
glands and pancreas) – Signs and symptoms that the hormone
glands are not working properly may include: headaches that will not
go away or unusual headaches, extreme tiredness, weight gain or weight
loss, dizziness or fainting, feeling more hungry or thirsty than
usual, hair loss, changes in mood or behavior (such as decreased sex
drive, irritability, or forgetfulness), feeling cold, constipation,
voice gets deeper, urinating more often than usual, nausea or
vomiting, stomach area (abdomen) pain

Severe Infusion Reactions – Signs and symptoms of infusion
reactions may include: chills or shaking, itching or rash, flushing,
shortness of breath or wheezing, dizziness, fever, feeling like
passing out, back or neck pain, and swelling of the face or lips

Before receiving TECENTRIQ, patients should tell their healthcare
provider about all of their medical conditions, including if they:

Have immune system problems (such as Crohn’s disease, ulcerative
colitis, or lupus); have had an organ transplant; have lung or
breathing problems; have liver problems; have a condition that affects
their nervous system (such as myasthenia gravis, or Guillain-Barre
syndrome); or are being treated for an infection

Are pregnant or plan to become pregnant

TECENTRIQ can harm an unborn baby

If patients are able to become pregnant, they should use an
effective method of birth control during treatment and for at
least 5 months after the last dose of TECENTRIQ

Are breastfeeding or plan to breastfeed

It is not known if TECENTRIQ passes into the breast milk

Do not breastfeed during treatment and for at least 5 months after
the last dose of TECENTRIQ

Patients should tell their healthcare provider about all the
medicines they take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.

The most common side effects of TECENTRIQ in people with urothelial
carcinoma include:

feeling tired

decreased appetite

nausea

constipation

urinary tract infection

diarrhea

fever

The most common side effects of TECENTRIQ in people with non-small
cell lung cancer include:

feeling tired

decreased appetite

shortness of breath

cough

nausea

muscle or bone pain

constipation

TECENTRIQ may cause fertility problems in females, which may affect the
ability to have children. Patients should talk to their healthcare
provider if they have concerns about fertility.

These are not all the possible side effects of TECENTRIQ. Patients
should ask their healthcare provider or pharmacist for more information.

Please visit http://www.Tecentriq.com
for the TECENTRIQ full Prescribing Information for additional Important
Safety Information.

About Genentech in Personalized Cancer Immunotherapy

For more than 30 years, Genentech has been developing medicines with the
goal to redefine treatment in oncology. Today, we’re investing more than
ever to bring personalized cancer immunotherapy (PCI) to people with
cancer. The goal of PCI is to provide each person with a treatment
tailored to harness his or her own immune system to fight cancer.
Genentech is studying more than 20 investigational medicines, 10 of
which are in clinical trials. In every study we are evaluating
biomarkers to identify which people may be appropriate candidates for
our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech in Lung Cancer

Lung cancer is a major area of focus and investment for Genentech, and
we are committed to developing new approaches, medicines and tests that
can help people with this deadly disease. Our goal is to provide an
effective treatment option for every person diagnosed with lung cancer.
We currently have four approved medicines to treat certain kinds of lung
cancer and more than 10 medicines being developed to target the most
common genetic drivers of lung cancer or to boost the immune system to
combat the disease.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.

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